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Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

Primary Purpose

Cow Milk Allergy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test extensively hydrolyzed formula
Control extensively hydrolyzed formula
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cow Milk Allergy

Eligibility Criteria

2 Months - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Born at term (>36 weeks gestation)
  • 2 months to <4 years of age at enrollment
  • Documented CMA within 6 months prior to enrollment
  • Otherwise healthy
  • Having obtained his/her legal representative's informed consent

Exclusion Criteria:

  • Children consuming mother's milk at the time of inclusion and during the trial
  • Any chromosomal or major congenital anomalies
  • Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay))
  • Immunodeficiency
  • Anaphylaxis to any food
  • Receiving free amino acid formula
  • Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol
  • Currently participating in another clinical trial

Sites / Locations

  • Hoag Medical Group
  • Stanford University
  • Clinical Research Institute
  • Midwest Clinical Research
  • Breathe America
  • Northwell Health System
  • Icahn School of Medicine at Mount Sinai
  • Allergy, Asthma and Clinical Research Center
  • Carolina ENT
  • Memphis & Shelby County Pediatrics
  • Houston Clinical Research Associates
  • Allergy Asthma Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test infant formula

Control infant formula

Arm Description

Test non-commercial extensively hydrolyzed infant formula with HMOs

Control non-commercial extensively hydrolyzed infant formula without HMOs

Outcomes

Primary Outcome Measures

allergic reaction post DBPCFC
subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators

Secondary Outcome Measures

stool characteristics
collected on daily diaries
formula intake
amount of formula ingested daily
adverse events
adverse events as reported by caregivers

Full Information

First Posted
July 19, 2017
Last Updated
January 28, 2019
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT03236207
Brief Title
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Official Title
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
November 6, 2018 (Actual)
Study Completion Date
November 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Infants/children with cow's milk allergy will take part in 2 double-blinded placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random order. If both food challenges are passed, subjects will be asked to consume the Test formula in an at-home open challenge for 7 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test infant formula
Arm Type
Experimental
Arm Description
Test non-commercial extensively hydrolyzed infant formula with HMOs
Arm Title
Control infant formula
Arm Type
Active Comparator
Arm Description
Control non-commercial extensively hydrolyzed infant formula without HMOs
Intervention Type
Other
Intervention Name(s)
Test extensively hydrolyzed formula
Intervention Description
extensively hydrolyzed formula with HMOs
Intervention Type
Other
Intervention Name(s)
Control extensively hydrolyzed formula
Intervention Description
extensively hydrolyzed formula without HMOs
Primary Outcome Measure Information:
Title
allergic reaction post DBPCFC
Description
subjects will be observed during and for at least 2 hours after the food challenge for any allergic reaction symptoms which will be documented by investigators
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
stool characteristics
Description
collected on daily diaries
Time Frame
1 week
Title
formula intake
Description
amount of formula ingested daily
Time Frame
1 week
Title
adverse events
Description
adverse events as reported by caregivers
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Born at term (>36 weeks gestation) 2 months to <4 years of age at enrollment Documented CMA within 6 months prior to enrollment Otherwise healthy Having obtained his/her legal representative's informed consent Exclusion Criteria: Children consuming mother's milk at the time of inclusion and during the trial Any chromosomal or major congenital anomalies Chronic medical diseases (ie seizure disorders, chronic lung disease, heart problems (heart murmurs okay)) Immunodeficiency Anaphylaxis to any food Receiving free amino acid formula Subject who in the Investigator's assessment cannot be expected to adhere to the study protocol Currently participating in another clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Nowak-Wegrzyn, MD
Organizational Affiliation
Mt Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hoag Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Facility Name
Stanford University
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Midwest Clinical Research
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Breathe America
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Northwell Health System
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
71320
Country
United States
Facility Name
Carolina ENT
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Memphis & Shelby County Pediatrics
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38116
Country
United States
Facility Name
Houston Clinical Research Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Allergy Asthma Research Institute
City
Waco
State/Province
Texas
ZIP/Postal Code
76633
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula

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